Work

Effect of vessel diameter on the clinical benefits of drug-coated balloon angioplasty: Insights from paclitaxel-coated balloon and polymer-free sirolimus-eluting stent studies

Year: 2026

Type: article

Abstract: BACKGROUND: 20 years ago, drug coated balloon (DCB) angioplasty was introduced into the interventionalist's toolbox initially to treat in-stent restenosis. Since then, considerable clinical evidence was generated in patients with de novo lesions. Whether drug-eluting stents (DES) or DCB angioplasty are associated with better clinical outcomes for de novo lesion treatment is still a matter of debate. OBJECTIVE: The objective of this post-hoc analysis was to assess the impact of vessel diameter in a real-world, unselected patient population treated with either paclitaxel-coated balloon (PCB) angioplasty or polymer-free sirolimus-eluting stent (PF-SES) implantation based on patient-level data. METHODS: Four all-comers observational studies based on similar protocols were pooled and vessel-diameter matched to study the clinical outcomes following revascularization with either PCB or PF-SES. The primary endpoint in all studies was the accumulated clinically driven target lesion revascularization (TLR) rate at 9-12 months complemented with secondary endpoints such as the rates for major adverse cardiac events (MACE), myocardial infarction (MI) and cardiac death. RESULTS: In the unmatched patient population, 3035 patients received either PCB (1614 patients) or PF-SES (1421 patients). The 'unmatched' TLR and MACE rates were low with 2.5% (PCB) vs. 2.0% (PF-SES, p = 0.319) and 4.5% (PCB) vs. 5.0% (PF-SES, p = 0.493), respectively. In the large vessel group (≥ 3 mm), 253 patient pairs were matched with reference diameters of 3.19 ± 0.27 mm (PCB) and 3.18 ± 0.27 mm (PF-SES, p = 0.787), and lesion lengths of 17.5 ± 9.8 mm (PCB) and 17.3 ± 7.1 mm (PF-SES, p = 0.839). The accumulated TLR rates were not significantly different (PCB 2.0% vs. PF-SES 2.8%, p = 0.786). Likewise, MACE rates in this large vessel subgroup were similar (5.6% vs. 6.4%, p = 0.723). In the small vessel group (< 3 mm), 420 patient pairs were matched with reference diameters of 2.49 ± 0.18 mm (PCB) and 2.49 ± 0.18 mm (PF-SES, p = .995), and lesion lengths of 16.0 ± 9.0 mm (PCB) and 16.7 ± 7.1 mm (PF-SES, p = 0.665). The accumulated TLR rates were not significantly different (PCB 1.9% vs. PF-SES 2.2%, p = 0.810). Likewise, MACE rates in the small vessel subgroup were similar (4.4% vs. 5.8%, p = 0.346). Individual clinical event rates were low and not significantly different between patients with small and large vessels. CONCLUSIONS: In this real-world experience PCB and PF-SES angioplasty were associated with low clinical event rates. There was no difference in clinical efficacy between PCB and PF-SES in large and small vessel PCI in terms of clinically driven TLR and MACE. Previously reported higher rates for clinical events after DCB angioplasty in large coronary vessels ≥ 3 mm could not be observed.

Source: Clinical Research in Cardiology

DOI: 10.1007/s00392-025-02819-w